An Open-label, Single Center, Phase I/II Clinical Trial to Assess the Maximum Tolerated Dose, Safety and Efficacy of BEY1107 in Combination with Capecitabine in Patients with Metastatic Colorectal Cancer Refractory or Intolerant to Standard of Care
This is a Phase 1/2 study to evaluate the maximum tolerated dose, safety and efficacy of BEY1107 in combination with capecitabine in patients with metastatic colorectal cancer refractory or intolerant to standard of care (SoC).
• Adult males and females aged over 19 years or older at the time of Informed Consent.
• Histopathologically or cytologically diagnosed with colorectal cancer.
• Patients with unresectable metastatic lesion(s).
• Patients who experienced treatment failure of colorectal cancer with the second-line or beyond standard chemotherapy (including fluoropyrimidine, oxaliplatin and irinotecan).
• Subjects who have at least one measurable or evaluable lesion as per RECIST v1.1.
• Subjects with ECOG performance status 0 or 1.
• Women of childbearing potential who are not surgically sterile must consent to practice acceptable contraception until 6 months after the end of IP administration and also have the evidence of not being fertile.
• Non-vasectomized men who consent to use an acceptable contraception by one-self and the partner until 3 months after the end of IP administration.
• Patients who are fully informed of this trial, voluntarily decide to participate in the trial and provide written consent to comply with requirements for the trial.